Two key House Democrats are pressing the Centers for Medicare and Medicaid Services (CMS) for more information about how Medicare plans to cover a new class of Alzheimer’s drug.
The agency last week detailed how Medicare beneficiaries enrolled in outpatient prescription medication coverage will be able to obtain the drugs once they are granted full approval from the Food and Drug Administration (FDA). The process involves patients and physicians participating in registries designed to track how the medicines perform in real-world settings.
But in a letter dated Monday, Reps. Anna Eshoo (Calif.), the ranking Democrat on the House Energy and Commerce’s health subcommittee, and subcommittee member Nanette Diaz Barragán (D-Calif.) said the agency “failed to answer basic questions” about how the registry would work.
For example, CMS did not say when the registry will be live and accessible for patients and clinicians and didn’t specify what data would be collected, or even how patients could find a doctor who is participating in the registry.
“There needs to be clarity and transparency about the standards for coverage for FDA-approved treatments for deadly diseases with unmet medical needs. Please do not allow CMS’s demand for additional evidence generation be a barrier to patient care,” the lawmakers wrote.
The treatments in question are monoclonal antibody infusions that target brain plaque known as amyloid, which is a signature characteristic of Alzheimer’s disease. The drugs are intended for early-stage Alzheimer’s patients and are meant to slow the progression of memory loss, but they are not a cure.
They are costly, and there are only two: Eisai’s Leqembi and Biogen’s Aduhelm. Both were granted accelerated approval by FDA, and the agency could grant full approval to Leqembi this summer.
An FDA advisory panel is scheduled to meet Friday to discuss Leqembi, and the agency’s decision deadline is July 6. CMS last week said patients would be able to obtain the drugs the same day they are approved.
Eshoo and Barragán wrote that despite the agency’s assertion, “the ability for beneficiaries to access the drug as soon as July 6, 2023 is still very unclear.”
They pressed CMS to change its policy and cover the drug broadly or to “immediately begin preparing for a registry that is clearly defined and minimizes provider and patient burden.”
